VENOUS LINE - COBE BAXTER 03-7301

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-02 for VENOUS LINE - COBE BAXTER 03-7301 manufactured by National Medical Care.

Event Text Entries

[4958] 69 y/0 pt. (with a cardiac hx) complained of chest pain 2 hours into her treatment. She was given nt 8 x 2 and place in 02 at 2 l without relief. Dialysis was discontinued and the pt. Transferred to the hosp. The pt. Has a svc that had poor flows. The blood flow was adjusted multiple times during thr treatment. The dr. Called from the hosp. And stated that the pt. Was hemoloyzed. The line was checked and no kinds were found. The dialysis machine was checked by the facility and no problem found, the cause of the hemoloysis is unknown but believed to be mechanical. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6734
• MDR Report Key: 6734
• Date Received: 1993-08-02
• Date of Report: 1993-06-28
• Date of Event: 1993-06-21
• Date Facility Aware: 1993-06-28
• Report Date: 1993-06-28
• Date Added to Maude: 1993-10-13
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VENOUS LINE - COBE BAXTER
• Generic Name: VENOUS BLOODLINE
• Product Code: KRK
• Date Received: 1993-08-02
• Catalog Number: 03-7301
• Lot Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 6417
• Manufacturer: NATIONAL MEDICAL CARE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-08-02